SureCath Set with Accessories, Coloplast Corp.-MN 06093, Sterile EO., Manufacturer Coloplast -A/S 3050 Denmark. 28022S 1

FDA device recall Z-2409-2011 · posted 2011-06-03 · Terminated

Recall details

Recalling firm

Coloplast Manufacturing US, LLC

Reason for recall

Coloplast has initiated a recall on SpeediCath with Insertion Supplies and SureCath Set with Insertion Supplies because they contain Iodine prep pads which may expire before the overall product expiration date. SpeediCath with Insertion Supplies and SureCath Set with Insertion Supplies are both packaged with a set of accessories which includes Iodine prep pads. The Iodine prep pads included i

Action taken

Coloplast Manufacturing US, LLC sent a Coloplast "Product Field Correction Notice" dated April 21, 2011. The letter was addressed to "Dear Valued Customer". The letter described the problem and the product involved in the recall. Customers were advised to provide the current inventory levels of the lots affected and the firm will be providing them with new iodine prep pads with sufficient shelf life. This product will include customer instructions, informing the customer to discard the original prep pads and use the new prep pads instead. If they prefer, they could themselves send the affected product back to Coloplast and they in return will attach new prep pads to the product for them. If they have further distributed the product, they advised consignees to contact their customers and to include the letter provided to them to inform them of the recall.

Root cause

Incorrect or no expiration date

Status

Terminated

Product code

EZD

Quantity affected

438,412

Distribution

Nationwide Distribution including AL, AZ, CA, CO, CT, DE, FL,GA, ID, IL, IA, MD, MA, MI, MN, MS, NJ, NY, NC, OH, OK, OR, PA,PR, SC, TN, TX VA, WA, WI.

Date initiated

2011-04-21

Date posted

2011-06-03

Date terminated

2012-04-24

Location

Minneapolis, MN